MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY® VERSA FIT® URETERAL STENT

Catalog Number 778600

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that the patient for stent removal and exchange experienced an adverse event directly attributable to the device 778600 - inlay versafittm multi-length ureteral stent without guidewire, 6fr., 22cm32cm and the patient experienced pain, discomfort.This did resulted in the patient injury requiring medical or surgical intervention.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to ¿material selection".A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states the following: "potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ extravasation ¿ ureteral reflux ¿ stent dislogdgement, fragmentation, migration, occlusion ¿ fistula formation ¿ loss of renal function ¿ hemorrhage ¿ pain/discomfort ¿ stent encrustation ¿ hydronephrosis ¿ perforation of kidney, renal pelvis, ureter and/or bladder ¿ ureteral erosion ¿ infection ¿ urinary symptoms" "with any ureteral stent, migration is a possible complication which could require medical intervention for removal.Selection of too short a stent may result in migration." "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the patient for stent removal and exchange experienced an adverse event directly attributable to the device 778600 - inlay versafittm multi-length ureteral stent without guidewire, 6fr., 22cm32cm and the patient experienced pain, discomfort.This did resulted in the patient injury requiring medical or surgical intervention.

• Brand Name: BARD® INLAY® VERSA FIT® URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18978326
• MDR Text Key: 338595148
• Report Number: 1018233-2024-01595
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014789
• UDI-Public: (01)00801741014789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 778600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention